Abstract | BACKGROUND: PATIENTS AND METHODS: Patients received XR5000 at the dose of 3010 mg/m(2) through a 120-h central venous infusion every 3 weeks. Toxicity was graded according to the Common Toxicity Criteria (CTC), version 2.0. An independent panel assessed response every two cycles according to the World Health Organization (WHO) criteria. Gehan's rule was used for sample size determination. RESULTS: Sixteen patients were enrolled; one patient was ineligible because of prior melphalan single agent treatment. Eastern Cooperative Oncology Group (ECOG) performance status was 0 (eight patients), 1 (five patients), or 2 (two patients). The 15 eligible patients received 43 cycles of XR5000 (median 2, range 1-8). Hematological toxicity was mild with only one grade 3 anemia in one patient. Other drug-related toxicities never exceeded grade 3 and included fatigue (four patients), thrombosis (one patient), nausea (one patient), stomatitis (one patient) as well as dyspnea/ cough (one patient). One patient who had refused further therapy and controls after the first cycle was not assessable for response evaluation. No objective responses were observed. Four patients experienced stable disease and 10 patients progressive disease. The median time to progression was 42 days (CI 95% 40; 54). CONCLUSIONS: The complete lack of any objective response does not justify further evaluation of XR5000 in patients with advanced ovarian cancer using this dose and schedule, although the therapy was generally well tolerated.
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Authors | Christian Dittrich, Veronique Dieras, Pierre Kerbrat, Cornelis Punt, Roberto Sorio, Francesco Caponigro, Xavier Paoletti, Christine de Balincourt, Denis Lacombe, Pierre Fumoleau |
Journal | Investigational new drugs
(Invest New Drugs)
Vol. 21
Issue 3
Pg. 347-52
(Aug 2003)
ISSN: 0167-6997 [Print] United States |
PMID | 14578683
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Acridines
- Antineoplastic Agents
- DACA, acridine
- Topoisomerase I Inhibitors
- Topoisomerase II Inhibitors
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Topics |
- Acridines
(administration & dosage, adverse effects, therapeutic use)
- Adult
- Aged
- Antineoplastic Agents
(administration & dosage, adverse effects, therapeutic use)
- Female
- Humans
- Infusions, Intravenous
- Middle Aged
- Ovarian Neoplasms
(drug therapy)
- Topoisomerase I Inhibitors
- Topoisomerase II Inhibitors
- Treatment Outcome
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